GB2076774A

GB2076774A - Moulded collapsible container

Info

Publication number: GB2076774A
Application number: GB8118625A
Authority: GB
Original assignee: Baxter Travenol Laboratories Inc
Current assignee: Baxter International Inc
Priority date: 1979-04-09
Filing date: 1980-04-08
Publication date: 1981-12-09
Also published as: NO801005L; IE832017L; IE800722L; SE8002610L; GB2076774B; ES249849Y; DE3013527A1; FR2453785A1; IE49674B1; BE882677A; CA1118389A; GB2047653A; NL8001978A; BR8002114A; CA1117487A; IE49673B1; ES249849U; AU5720580A; US4308904A; GB2047653B

Description

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GB 2 076 774 A 1

SPECIFICATION

Moulded Collapsible Container

In U.S. Patent Nos. 4,049,033 and 4,088,166, among others, a moulded collapsible solution 5 container is disclosed which collapses relatively easily under low suction pressures, and thus finds particularly desirable use as a container for parenteral solutions.

In according with this invention, there is 10 provided a moulded, collapsible container, which container has a chamber-defining body portion integral with a shoulder portion and a neck portion at one end of the body portion, said shoulder portion having opposed shoulder edges 15 and a pair of opposed lines of flexing weakness defined in the collapsible body portion and exhibiting a cross section which extends inwardly of said container, said opposed lines of flexing weakness being positioned on each side of the 20 container in generally parallel relation to said opposed shoulder edges, said opposed lines of flexing weakness being longitudinally spaced from the shoulder edges by a distance which is proportioned to cause said opposed lines of 25 flexing weakness to enter into abutting relationship with one another as the container collapses inwardly about said opposed shoulder edges, whereby the abutting lines of flexing weakness inhibit further collapse of the container 30 under the pressure of suction, to slow the rate of subsequent collapse.

The distance between each opposed shoulder edge and its associated line of flexing weakness is, preferably, more than half of, but less than the 35 spacing between the opposed shoulder edges,

this distance being, advantageously, no more than 60 per cent of said spacing.

This arrangement permits the rate of draining of the container to decrease substantially when 40 the container has almost collapsed completely, so that the drainage does not terminate completely for a significant period of time. Accordingly, the container may be designed for parenteral solution therapy with the 1000 ml. or other desired 45 dosage capacity, but also with a small amount (for example 50 cc.) of extra capacity of parenteral solution. Accordingly, the bag can be designed so that about 900 cc. of parenteral solution can be administered normally, but in the 50 event that the nurse does not arrive at that time, the administration flow does not altogether cease, but merely slows down for the last 150 cc. or so, with the result that clotting of the needle is prevented, as takes place when no flow is passing 55 through the administration set. At the same time, because of the reduced flow following the administration of the basic amount of solution, there is no series overdose of the patient.

Referring to the drawings, Figure 1 is an 60 elevational view of a container (which is not according to this invention) shown in its mould halves which form it, with portions of the nearer mould half being broken away.

Figure 2 is a perspective view of the container

65 in collapsed configuration.

Figure 3 is a plan view of the container in its initial, unstressed configuration.

Figure 4 is an elevational view of the container in its initial, unstressed configuration. 70 Figure 5 is an elevational view similar to Figure 4, showing the container in partially collapsed configuration as liquid is removed through the neck of the container.

Figure 6 is a fragmentary elevational view of 75 the container, showing it in substantially completely collapsed configuration, as the last of the liquid contents is being drained from it.

Figure 7 is an elevational view, rotated 90° about the longitudinal axis from the view of Figure 80 6, showing the container in substantially completely collapsed configuration.

Figure 8 is a transverse sectional view taken along line 8—8 of Figure 4.

Figure 9 is a transverse sectional view taken 85 along line 9—9 of Figure 4.

Figure 10 is a transverse sectional view taken along line 10—10 of Figure 4.

Figure 11 is a transverse sectional view taken along line 11 —11 of Figure 4.

90 Figure 12 is an elevational view of a container according to this invention in its initial, as-moulded, unstressed configuration.

Figure 13 is a perspective view of the container of Figure 12.

95 Figure 14 is a sectional view taken along line

4—4 of Figure 13.

Figure 15 is a sectional view taken along line

5—5 of Figure 15.

Figure 16 is a longitudinal sectional view of the 100 container of Figures 12 and 13, showing the container in almost completely drained configuration.

Figure 17 is an elevational view of the container of Figures 12 and 13 showing it in 105 completely drained configuration.

Referring to the drawings, the moulded, collapsible solution container 10 is shown positioned within a pair of mould halves 12,14 which are used in conjunction with conventional 110 blow-moulding apparatus for the manufacture of the container.

Container 10 has a chamber-defining body portion wall 16, and an integral neck portion 18 adapted for receiving a conventional sterile-seal 115 closure for parenteral solution containers, and a shoulder portion 20.

As in the previously cited patents, the container may define, in its normal, unstressed state, a transverse crosssection which tapers from 120 the shoulder portion 20, as shown for example in Figure 4, progressively along a major portion of its length to a flat, sealed end portion 22 at the end of the container opposite to the one end which carries the shoulder portion. Preferably, the 125 tapering begins at the shoulder portion 20, and proceeds in generally continuous manner to the sealed end 22.

The specific design of sealed end 22 may be in accordance with the method and design

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described in U.S. patents 4,105,730 and/or 4,076,063, or a simple double bar end seal may be used.

End 22 of container 10 has a convex, arcuate seal line 24. The convex, arcuate configuration of the seal line 24 provides improved strength to the seal, which is particularly desirable as in the specific embodiment involving thin sheets of preferably oriented plastics material, which is generally difficult to seal in a reliable and strong manner.

The wall thickness of the container of this application is preferably about 0.01 to 0.02 inch (0.025 to 0.050 cm) in thickness, and is generally uniform about the entire chamber-defining body portion 16 of the container, while the neck portion 18 is typically of greater wall thickness so as to be relatively stiff. Shoulder portion 20 is desirable as thin as body portion 16 about its edges, and is thicker at central portions thereof, for example about 0.03 inch thick.

A thin line of flexing weakness 26 of arcuate cross-section may be formed in opposed relation along the longitudinal edges of the container, as shown in the drawings, to facilitate the flat collapse along the length of the bag.

The flat end 22 defines a flat extension 28 which may be utilized as a hanger member, as shown in Figure 2, for example.

The shoulder portion 20 is rectangular in shape (square in this example). Furthermore, as specifically shown in Figure 7, the various transverse crosssections exemplified at 30 of the container exhibit wall circumferences which progressively decrease in length along the container from adjacent the shoulder portion 20 toward the opposite end 22 thereof. Accordingly, the collapsed container exhibits a taper from the shoulder to the other end which has been found to be beneficial in providing a flat, planar collapse, rather than collapsing flat to a generally non-planar, slightly buckled structure, as in the prior art.

This provides a significant advantage of permitting the collapsed bags, prior to filling, to receive printing on the face of the bag itself to function as a label, with volume indicia for indicating the amount of liquid withdrawn from the bag, or any other desired information.

As a further contribution to the planar configuration that most of the bag can occupy, (with the exception of the shoulder and neck portions and end 22) in its collapsed configuration, the bag tapers uniformly from the shoulder end 20 to the tail end 24 without the use of a non-tapered section in body wall portion 16, as has been shown in the prior art.

Other examples of the tapered cross-section are shown in Figures 2 through 11.

The collapsible container may also define gusset portions 32, 34, which facilitate the outward spreading of the container wall adjacent shoulder 20 on the axis between the gussets (as shown in Figure 7), while the container simultaneously collapses inwardly from the view point of the axis perpendicular to the axis between the gussets 32, 34 (as shown in Figure 6).

The gussets 32, 34 are positioned in opposed relation to each other or opposite side of the bag . adjacent the shoulder portion, at opposed ends thereof. The gusset portions 32, 34 include lines of weakness to facilitate the collapse of the container adjacent the shoulder portion as the contents are withdrawn. These lines include lines 36 and 38 which may be lines of arcuate cross-section, similar to lines 26, to faciliate flexing.

Each gusset portion 32, 34 is a triangular structure defining three sides, i.e., sides 36, 38 and 40, side 40 of the gusset defining a line which is parallel to the corresponding shoulder edge 42 and preferably, as shown, is coextensive with shoulder edge 42.

Shoulder edge 42 may alternatively define the shape of an enlarged, generally cylindrical section to permit flexing motion of its associated gussets 32, 34 into the outspread relationship of the gussets to the shoulder 20 as shown in Figure 7. However, as shown, shoulder edge 42 simply defines an angled line surface to form a relatively sharp corner.

Shoulder 20 also defines a second pair of opposed shoulder edges 44, which may preferably be of relatively enlarged, generally cylindrical section construction, typically of 0.05 to 0.3 inch (0.13 to 0.76 cm) diameter, extending between the gussets.

The above fold lines of the shoulder edges, the gussets, and elsewhere may specifically be of the cross-sectional shape as defined in U.S. Patent No. 4,090,541 for desired flexing characteristics.

A pair of opposed lines of flexing weakness 46 is defined in the container. Lines 46 exhibit an arcuate cross-section to facilitate flexing of the material, the cross-sectional diameter of said lines being preferably from 0.05 to 0.2 inch (0.13 to 0.51 cm) and specifically about 0.1 inch (0.254 cm).

The opposed lines of flexing weakness 46 are positioned on each side of the container in parallel relation to the second pair of shoulder edges 44, _ being preferably spaced from the shoulder edges in the direction of the flat, sealed end portion by a distance of one sixteenth to one quarter of the length of the container, as measured from the shoulder portion 20 to the flat, sealed end portion 22 and preferably adjacent to but typically about 0.05 to 0.2 inch (0.13 to 0.51 cm) displaced toward end 24 from a line extending between the apexes of each gusset 32, 34, typically being so displaced about 0.1 inch (0.25 cm). For a container which measures about 10 inches (25 cm) between the shoulder edges 42 and the beginning of the flat, sealed end portion 22, opposed lines of flexing weakness 46 may be positioned about 1 or 2 inches (2.5 to 5 cm) from the shoulder edges 44, and specifically about 1.3 inches (3.3 cm).

Preferably, each of the second shoulder edges 44 and its associated parallel line of flexing

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weakness 46 defines an area 48 between them in the container which is essentially planar in the original, unstressed, as-moulded condition of the container. Each planar area 48 may be roughly 5 rectangular in shape in the embodiment as 70

shown, in which the lines of folding weakness 46 are each positioned centrally and transversely on the container, and are of approximately equal length to shoulder edges 44.

10 In other words, line 46 is positioned at 75

approximately the same axial position of bag 10 as the apexes 47 of each gusset. Also, preferably,

line 46 is of a length corresponding to edge 44 of shoulder 20 so as to define the rectangular planar 15 area 48, and also to define triangular areas 49 on 80 each side of each rectangular area 48, which are each of a shape and area equal to a triangular half 51 of its adjacent gusset 32, 34 as shown for example in Figure 3. Accordingly, when the 20 container folds, each triangular area 49 can fold 85 up against one half of its adjacent gusset 32, 34 for a flat, efficient fold.

Furthermore, in the collapsed condition as shown in Figure 7, the distance between apexes 25 47 of the gussets is preferably equal to one half of 90 the circumference of body 10 in the cross-section that defines the two apexes 47. This further facilitates flat folding.

Also, it should be noted that line of weakness 30 46 defines an inwardly extending arc, while the 95 other lines of weakness in the container preferably define outwardly extending arcs.

Referring specifically to Figures 8 to 11, the tapering cross-section of the container, in its as-35 moulded, original, unstressed configuration can 100 be seen.

Specifically, it can be seen that along the majority of the length of the container, beginning adjacent the shoulder portion, the cross sections 40 (specifically the cross sections of Figures 8 105

through 10) exhibit mutually perpendicular major axes 60 and minor axes 62 in which the major axes are longer than the minor axes. In each cross section, there is seen a pair of opposed, outwardly 45 angled wall portions each of which define a 110

generally acutely angled apex 64, 66 moulded into the bag, which facilitates the flat collapse of the bag. The two apexes 64, 66 are both positioned on major axis 60.

50 Furthermore, the majority of transverse cross 115 sections (as shown in Figure 8 through 10) exhibit generally planar central areas 68, 70 adjacent the minor transverse axes 62.

At the generally lateral portions of the bag, 55 curved portions 72 are defined between the 120

generally planar portions 68, 70 and apexes 64, 66 of the general shape as shown in the drawings.

The tail end of bag 10, as shown in Figure 11, 60 may exhibit rounded peripheral areas 74, 76 125

adjacent major axes 60 if desired. Alternatively, the apexes 64, 66 may continue the entire distance to the seal line 24.

It should also be noted that apexes 64, 66 65 define the thin lines of flexing weakness 26 130

described previously and shown, for example, in Figures 1 and 2.

The above configuration shown in Figures 8 to 11 further facilitates the flat collapse of the container which permits, for example, the direct printing of a label on the container prior to filling.

The container may be filled with parenteral solution and sealed with a conventional sterile seal which is typified by sterile seal 48 as shown, having a sealing cover 53 and tubular access member or members 50, generally with a piercable diaphragm within the access member.

A conventional solution set 52, having a piercing spike 54, may penetrate the tubular access member 50 for access to the container, which container may be placed upon a hanger 56, for example an IV pole or the like.

As in conventional IV solution therapy, container 10 may be hung in inverted position, approximately two to three feet or more above the patient, to provide sufficient gravity pressure to administer the solution and also to cause the collapse of the container as the solution is drained. Figure 5 shows the partial collapse of the container, with the walls of the container flexing into flat configuration along lateral lines of weakness 26.

As the container is completely drained, and as shown in Figures 6 and 7, gussets 32, 34 fold outwardly while central portions 58 of the bag wall collapse inwardly, with the lines of flexing weakness 36, 38 and shoulder edges 42,44 flexing to permit this motion.

Referring to Figures 12 to 17, a moulded, collapsible solution container defining a chamber-defining body portion wall has an integral neck portion 18 and a shoulder portion 20 at one end thereof. The container may also define, it desired, a pair of opposed gusset portions 32,34 adjacent the shoulder portion and at opposite ends of the shoulder portion. The shoulder portion defines opposed shoulder edges 44 extending between the gusset portions, when present, and a pair of opposed lines of flexing weakness 46 defined in the collapsible solution container and exhibiting an arcuate cross section which extends inwardly of the container.

The opposed lines of flexing weakness 46 are positioned on each side of the container in generally parallel relation to the opposed shoulder edges. The opposed lines of flexing weakness 46 are longitudinally spaced from the shoulder edges 44 by a distance which is proportioned to cause the opposed lines of flexing weakness to enter into abutting relationship with one another as the container collapses inwardly iabout the opposed shoulder edges.

As the result of this, the abutting lines of flexing weakness inhibit further collapse of the container under the pressure of suction, to slow the rate of subsequent collapse.

Accordingly, the container may be used as a container for parenteral solution, being hung on an IV pole in conventional manner and communicating through a parenteral solution

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administration set and an IV needle to the venous system of a patient. As the container collapses, the walls rotate inwardly about the opposed shoulder edges until the opposed lines of flexing 5 weakness 44 enter into their abutting relationship. Following this, the container is capable of further collapse, but, due to the resistance provided by the abutting lines of flexing weakness, the rate of collapse at a substantially 10 unchanged suction head imparted by parenteral solution in the set below the container is substantially reduced, providing the desired effect of reduced but positive liquid flow out of the container, as described above.

15 The distance between each opposed shoulder edge 44 and the respective lines of flexing weakness 46 must be more than one half of the distance between the opposed shoulder edges, so that it is possible for the lines of flexing weakness 20 to enter into abutting relationship as the container collapses. Preferably, the distance between each opposed shoulder edge and its associated line of flexing weakness should be less than the spacing between the opposed shoulder edges. Typically, 25 the spacing is substantially less, for example, no more than 60 per cent of the spacing between the opposed shoulder edges.

Specifically, the distance from the centre of line of flexing weakness 46 to the centre of its 30 associated shoulder edge 44 may be about 1 — 5/6 inches (4.67 cm). On the other hand, the distance between the respective shoulder edges 44 may be about 2—1/2 inches. As the result of this, as shown in Figure 16, as the solution 35 container collapses, lines of flexing weakness 46 enter into abutting relationship with each other, while a certain amount of liquid volume 53 and air volume 55 remains in the almost-collapsed container. It is at this point that the flow rate out 40 of the container at substantially unchanged level of suction pressure is substantially diminished, but still remains a positive flow rate of a few cc. per hour, so that the IV needle is not clotted, but at the same time, the patient is not overdosed. 45 Lines 46 have an inwardly extending cross section, to abut each other as the container collapses, impelled by the liquid suction head in administration set 56, which may be connected at its other end to the venous system of a patient. 50 Also, lines 46 preferably occupy only a central portion of the container, as shown in Figure 12, being laterally spaced from each apex 47 of the gussets 32, 34.

Ultimately as shown in Figure 17, the container 55 can completely drain to flat configuration, and the flow stops, but, due to the resistance imparted by the abutting, inwardly extending lines of flexing weakness 46, a considerable period of time takes place with low flow rate, sufficient to prevent 60 clotting in the intravenous solution needle, until the supply of solution in the container is exhausted. This gives the nurse added time to check the patient and to replace the container with a new, filled container. If the needle becomes 65 clotted, it must be removed, and a new intravenous puncture must be made with a fresh set.

The curved portions 72, 72' (Figures 14 and 15) defined between the generally planar portions 68, 70 and the apexes 26 defining the longitudinal edges of the container define a curved surface. The curved surface is of a shape which is definable by a series of diverging, non- , intersecting straight lines 74. Also, the curved surfaces are of such a shape that straight lines of intersection are formed between curved surfaces 72, 72' and a series of parallel planes 80 positioned parallel to the longitudinal axis 76 of the container and perpendicular to the major transverse axis of the container as illustrated for * example by axes 60 of Figures 14 and 1 5. In other words, the planes are parallel to the various axes 62 of the same figures. This particular type of curved surface provides improved collapsibility at low suction pressure for the container into a flat configuration as illustrated by Figure 17.

The improved mode of collapse of the container of this application permits the use of less air in the container to provide a meniscus to read the remaining liquid level in the container.

Claims

1. A moulded, collapsible container, which container has a chamber-defining body portion integral with a shoulder portion and a neck portion at one end of the body portion, said shoulder portion having opposed shoulder edges and a pair of opposed lines of flexing weakness defined in the collapsible body portion and exhibiting a cross section which extends inwardly of said container, said opposed lines of flexing weakness being positioned on each side of the container in generally parallel relation to said opposed shoulder edges, said opposed lines of flexing weakness being longitudinally spaced from the shoulder edges by a distance which is proportioned to cause said opposed lines of flexing weakness to enter into abutting relationship with one another as the container collapses inwardly about said opposed shoulder edges, whereby the abutting lines of flexing weakness inhibit further collapse of the container under the pressure of suction, to slow the rate of subsequent collapse.

2. The container of Claim 1 in which the distance between each opposed shoulder edge and its associated line of flexing weakness is more than one half of but less than the spacing between the opposed shoulder edges.

3. The container of Claim 2 in which said distance is no more than 60 per cent of the spacing between the opposed shoulder edges.

4. The container of Claim 1, 2 or 3 in which said opposed lines of flexing weakness have a cross sectional diameter of from 0.05 to 0.2 inch (0.12 to 0.51 cm).

5. The container of any one of Claims 1 to 4 in which its normal, unstressed state, tapers from the shoulder portion progressively along a major

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portion of its length to a flat, sealed end portion at the end of said container opposite to the one end.

6. The container of any one of Claims 1 to 5 in which the shoulder portion is rectangular in 5 shape, with the wall circumferences of the transverse cross sections of the body portion progressively decreasing in length from adjacent the shoulder portion towards the opposite end.

7. The container of Claim 6 in which said flat, 10 sealed end has a convex, arcuate seal line.

8. The container of any one of Claims 1 to 7 wherein the container also has a pair of opposed gusset portions adjacent said shoulder portion at opposite ends of said shoulder portion.

Printed for Her Majesty's Stationery Office by the Courier Press, Leamington Spa, 1981. Published by the Patent Office, 25 Southampton Buildings, London, WC2A 1 AY, from which copies may be obtained.